Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) (PEP)

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Completed
Phase 3

Conditions

Common Cold

Treatments

Dietary Supplement: Echinacea
Other: Blinded placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00065715
BarrettB
R01AT001428 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects; The effect of receiving blinded placebo, compared to no treatment; and The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Full description

As per Brief Summary

Enrollment

719 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Suspected or known cold

At least one of the following cold symptoms:

nasal discharge, nasal congestion, sneezing, or sore throat

Enrolled in school, for children 12 to 17 years of age

Exclusion criteria

  • Pregnancy;
  • Symptom duration > 36 hrs
  • Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
  • Anticipated need for symptom-relieving meds during cold
  • Autoimmune/deficiency disease
  • History of allergic rhinitis with current eye itching/sneezing
  • History of asthma w/current cough/SOB
  • Prior study entry
  • Allergy to Echinacea

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

719 participants in 4 patient groups, including a placebo group

A
No Intervention group
Description:
No pills
B
Placebo Comparator group
Description:
Blinded placebo
Treatment:
Other: Blinded placebo
C
Experimental group
Description:
Echinacea - Blinded
Treatment:
Dietary Supplement: Echinacea
D
Experimental group
Description:
Echinacea - Unblinded, Open Label
Treatment:
Dietary Supplement: Echinacea

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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